FDA 510(k) Application Details - K110335

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K110335
Device Name	Bracket, Ceramic, Orthodontic
Applicant	ORTHO ORGANIZERS, INC. 1822 ASTON AVENUE CARLSBAD, CA 92008-7603 US Other 510(k) Applications for this Company
Contact	FOSTER BOOP Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2011
Decision Date	05/19/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review